High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy
NCT ID: NCT06241963
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-02-12
2026-06-30
Brief Summary
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Detailed Description
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At least 90 participants were randomized (1:1:1) to receive "bilateral active" ,"Unilateral active" or "Sham" treatment protocol. The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the tDCS treatment, the patients had receiving a battery measure of neuropsychological tests, Magnetic resonance imaging scan in multimodalities, VEEG and Resting motor threshold.
The clinical symptom of participants were followed 4 weeks and 12 weeks after the last treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Unilateral real High definition transcranial direct current stimulation
The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.
Active Comparator: Unilateral real High definition transcranial direct current stimulation
Improvement of cortical excitability, unilateral stimulation was effective, and no side effects were observed
Bilateral real High definition transcranial direct current stimulation
The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart.. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays.
Active Comparator: Bilateral real High definition transcranial direct current stimulation
Improved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed
Sham High definition transcranial direct current stimulation
The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10.
The 30 subjects were randomly divided into two groups, 15 receiving bilateral Sham HD-tDCS and 15 receiving unilateral Sham HD-tDCS.
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Sham Comparator: Sham High definition transcranial direct current stimulation
The sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors
Interventions
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Active Comparator: Unilateral real High definition transcranial direct current stimulation
Improvement of cortical excitability, unilateral stimulation was effective, and no side effects were observed
Active Comparator: Bilateral real High definition transcranial direct current stimulation
Improved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed
Sham Comparator: Sham High definition transcranial direct current stimulation
The sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors
Eligibility Criteria
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Inclusion Criteria
* Right-handed and aged 18-50 years old and primary school education or above;
* No major neurological or mental illness, no head injury, alcohol dependence or drug dependence;
* During the experiment, the subjects did not smoke, drink, get sick and take psychotropic drugs, and there were no major life events that caused mood changes.
Exclusion Criteria
* Have a history of substance abuse and drug dependence, or have used antipsychotic drugs in the past three months, and have serious suicidal tendencies;
* There are contraindications for MRI or EEG or transcranial magnetic stimulation.
18 Years
50 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Director of medical psychological department, Anhui Medical University
Locations
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Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHMU-tDCS-epilepsy
Identifier Type: -
Identifier Source: org_study_id
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